Trodelvy (sacituzumab govitecan-hziy)

P1/2, N=314, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed

Alterations in FGFR3, commonly found in the luminal-papillary molecular subtype associated with low response to immunotherapy, are the target of erdafitinib. Enfortumab vedotin, which targets Nectin-4 (expressed in >95% of urothelial carcinomas), is approved for patients who progress after chemotherapy and/or immunotherapy...Sacituzumab govitecan, an antibody-drug conjugate directed against Trop-2, is effective in basal, luminal and stroma-rich subtypes but not in neuroendocrine carcinomas. In addition, therapies developed for HER2-positive breast cancer have shown efficacy in urothelial carcinoma, with recent data from the DESTINY pan-tumour phase II trial leading to FDA approval of trastuzumab deruxtecan for HER2-overexpressing metastatic urothelial carcinoma. This paper is a comprehensive review of the molecular pathology of bladder cancer, highlighting advances in molecular classification, biomarkers and personalized therapies. The transition from morphology-based classifications to combined morphological and molecular approaches, with therapeutic implications, is also addressed.

Triple-negative breast cancer (TNBC) patients undergoing sacituzumab govitecan (SG) therapy suggests CTCs can be successfully detected...With the unique advantages of cell viability preservation, 100% diagnostic specificity, modular design adaptability, and cost-effectiveness, the PM-PAM platform establishes a new paradigm for liquid biopsy applications. This technology also shows the particular promise for monitoring antibody-drug conjugate (ADC) treatment efficacy through dynamic Trop-2 expression analysis in breast cancer management.

Therapies targeting DNA repair pathways, angiogenesis, and androgen receptor signaling-particularly via PARP inhibitors and antibody-drug conjugates like sacituzumab govitecan-have demonstrated clinical benefit...This review delineates recent developments in targeted and immunotherapeutic strategies, emphasizing the role of TILs in shaping treatment response and highlighting combinatorial approaches that synergize molecular targeting with immunomodulation. Through a comprehensive understanding of TNBC's molecular and immune landscape, we propose new therapeutic trajectories to improve clinical outcomes in this challenging malignancy.

P2, N=30, Not yet recruiting, First Hospital of China Medical University

This first international real-world series of SG in mMpTNBC shows clinically relevant activity and manageable toxicity, addressing a critical evidence gap and supporting further prospective studies, particularly in PD-L1-positive disease.

While SG has shown significant clinical benefit, the objective response rate (ORR) observed with SG in pretreated mTNBC patients in the Phase I/II basket study was 33.3%, indicating a heterogeneous response profile to SG. This article explores the potential influence of autophagy, senescence, and the patient's immune system on the treatment response.

P1/2, N=76, Active, not recruiting, MedSIR | Recruiting --> Active, not recruiting

P2, N=50, Completed, MedSIR | Active, not recruiting --> Completed

P1/2, N=46, Active, not recruiting, H. Lee Moffitt Cancer Center and Research Institute | Trial primary completion date: Apr 2026 --> Sep 2025

Recent trials demonstrate encouraging outcomes with ADC such as Enfortumab Vedotin (EV), Sacituzumab Govitecan (SG), Trastuzumab Deruxtecan (T-DXd), and Disitamab Vedotin (DV) in UC, improving response rates and Progression-Free Survival (PFS). In RCC, ADC against ENPP3, CD70, and TIM-1 show durable responses in early trials, though challenges such as dose-limiting toxicities require further investigation. Overall, this review underscores ADC as a transformative approach in uro-oncology, highlighting ongoing advancements in combination strategies and biomarker-driven applications to refine therapeutic outcomes and expand treatment options for these challenging malignancies.

P3, N=614, Active, not recruiting, Merck Sharp & Dohme LLC | Recruiting --> Active, not recruiting